A controversial cervical cancer vaccine that has been only recommended for U.S. residents has become a requirement for all new female immigrants ages 11 to 26, sparking an outcry over the order's safety and cost.
"It's outrageous," said Sara Sadhwani, project director for the Asian Pacific American Legal Center of Southern California. "It seems absolutely premature to mandate this for immigrant women."
The requirement went into effect Aug. 1 and will apply to more than 130,000 immigrants a year.
The U.S. Food and Drug Administration in June 2006 approved the vaccine Gardasil for females ages 9 to 26 to block strains of the human papillomavirus, or HPV, a sexually transmitted virus that can cause cervical cancer. About 4,000 women in the U.S. die of cervical cancer each year.
The national Centers for Disease Control and Prevention quickly recommended the vaccine for 11- and 12-year-old girls, with catch-up shots up to age 26. (The vaccine works best if given before a young woman is sexually active and may have already contracted the virus.)
A 1996 immigration law directs the Citizenship and Immigration Services to require that new immigrants receive inoculations that the CDC's immunization committee recommends for U.S. residents.
"It's not really a decision of ours," said immigration service spokeswoman Sharon Rummery. "We can't cherry-pick the recommendations."
Foreigners applying for permanent residency must get medical exams and vaccines against such highly contagious diseases as measles, meningitis and polio.
CDC spokesman Curtis Allen said that his agency's immunization committee, an advisory panel of physicians, did not consider the immigration implications of its decision.
"They made the recommendation based on the effectiveness and importance of the vaccine," he said. "That's their charge, and not immigration."
The CDC, Allen said, stands by its recommendation.
Although most medical organizations echo the CDC's advice that Gardasil be part of routine vaccinations, it has not been universally embraced. About a quarter of U.S. teen girls -- roughly 2.5 million -- received at least one of the three-shot series in the vaccine's first full year of distribution, according to the CDC reports. The goal is 90%. Only Virginia has made Gardasil mandatory.
There have been concerns about the vaccine's potential side effects. As of June 30, the FDA had received 9,749 "adverse events" reports from physicians and patients after Gardasil injections. Most involved pain at the injection site, headaches, nausea, fainting or fever.
The 6% of incidents that were deemed serious included 20 deaths as well blood clots and several cases of Guillain-Barre syndrome, an autoimmune disease that can lead to paralysis. The FDA says there is no evidence that Gardasil caused the deaths or led to Guillain-Barre.
Still, some physicians believe that the vaccine's safety has not been adequately proven. Dr. George F. Sawaya, a UC San Francisco obstetrician-gynecologist who specializes in cervical cancer, called the CDC recommendation "premature" because the vaccine is so new.
"We don't know what the long-term effects will be," he said.
The vaccine blocks four strains of HPV, two of which cause about 70% of cervical cancers. The other two cause most genital warts, which can be a painful nuisance.
Hailed by many as a huge breakthrough in women's health, Gardasil is seen by others as only modestly effective. A three-year study published last year in the New England Journal of Medicine found that the vaccine reduced the incidence of precancerous lesions by just 17% overall, in part because many of the young women in the study had already been exposed to the virus.
That caveat is particularly relevant for immigrants.
"Many women will very likely get this only for the purpose of the visa," said Kate Bourne, a vice president of the New York-based International Women's Health Coalition. "Quite likely they will be at the upper end of the age range, which means they are more likely to already be sexually active, and this vaccine is useless to them."
And because only the first shot is required before applying to immigrate, there is no guarantee that applicants will complete the three-shot series, rendering the inoculation "triply meaningless," Bourne said.
Consumer advocates have also complained that the vaccine is too expensive.
The CDC's stamp of approval ensures that some private insurance plans as well as U.S. programs for the poor will cover the steep price -- $360 for the series, plus the cost of office visits. But that's no help to applicants outside the country or not eligible for U.S. aid.
"This is just an additional barrier to coming to America," said Tuyet G. Duong, a senior attorney for the Asian American Justice Center, a civil rights group based in Washington, D.C. "It just adds another layer to what has become a toxic environment for immigrants."
Angelica Salas, executive director of the Coalition for Humane Immigrant Rights of Los Angeles, agrees.
"We don't want to convey that we don't want individuals to make healthy choices or seek out preventive healthcare," she said. "We just don't see why it should be linked to immigration."